Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2. (VÄSTKOST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hans Guldbrand, Vårdcentralen Lyckorna
ClinicalTrials.gov Identifier:
NCT01005498
First received: October 30, 2009
Last updated: December 4, 2011
Last verified: December 2011

October 30, 2009
December 4, 2011
March 2009
March 2011   (final data collection date for primary outcome measure)
Laboratory findings and body composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01005498 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.
Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.

The purpose of the clinical trial is to investigate whether low carbohydrate diet is better than the traditional diabetic diet in the treatment of patients with diabetes mellitus type 2, for blood sugar and body weight.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes
  • Dietary Supplement: Low carbohydrate - high fat diet
    The diet has an energy content of 1600 kcal or 1800, with 50% from fat, 20% from carbohydrates and 30% from proteins.
  • Dietary Supplement: High carbohydrate - low fat diet
    The diet has an energy content of 1600 or 1800 kcal, with 30% from fat, 55-60% from carbohydrates and 10-15% from proteins.
  • Experimental: Low carbohydrate diet (F)
    The group attended to low carbohydrate diet
    Intervention: Dietary Supplement: Low carbohydrate - high fat diet
  • Active Comparator: Traditional diet (K)
    The group attended to traditional diet
    Intervention: Dietary Supplement: High carbohydrate - low fat diet
Guldbrand H, Dizdar B, Bunjaku B, Lindström T, Bachrach-Lindström M, Fredrikson M, Ostgren CJ, Nystrom FH. In type 2 diabetes, randomisation to advice to follow a low-carbohydrate diet transiently improves glycaemic control compared with advice to follow a low-fat diet producing a similar weight loss. Diabetologia. 2012 Aug;55(8):2118-27. doi: 10.1007/s00125-012-2567-4. Epub 2012 May 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
December 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diabetes mellitus type 2

Exclusion Criteria:

  • Severe psychiatric disease or difficulties in understanding Swedish language.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01005498
M216-08
No
Hans Guldbrand, Vårdcentralen Lyckorna
Vårdcentralen Lyckorna
Not Provided
Principal Investigator: Hans G Guldbrand Vårdcentralen Lyckorna
Vårdcentralen Lyckorna
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP